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CYSTEAMINE HYDROCHLORIDE
CYSTEAMINE HYDROCHLORIDE is a Cystine-depleting agents drug. It is currently FDA-approved (first approved 2012) for Corneal cystine crystal deposits in cystinosis.
Cysteamine depletes cystine by converting it to cysteine and cysteine-cysteamine mixed disulfides, reducing corneal cystine crystal accumulation.
Cysteamine Hydrochloride is a marketed drug primarily indicated for the treatment of corneal cystine crystal deposits in cystinosis. Its key strength lies in its mechanism of action, which effectively depletes cystine by converting it to cysteine and cysteine-cysteamine mixed disulfides, thereby reducing corneal cystine crystal accumulation. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | CYSTEAMINE HYDROCHLORIDE |
|---|---|
| Drug class | Cystine-depleting agents |
| Target | Cystine |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
| First approval | 2012 |
Mechanism of action
Cysteamine works by acting as a cystine-depleting agent. It converts cystine into cysteine and cysteine-cysteamine mixed disulfides, which helps reduce the accumulation of cystine crystals in the cornea.
Approved indications
- Corneal cystine crystal deposits in cystinosis
Common side effects
- eye pain
- vision blurred
- eye irritation
- ocular hyperaemia
- instillation site discomfort
- eye pruritus
- lacrimation increased
- ocular deposits
Key clinical trials
- Effectiveness of a Bilayering Serum and Cream Containing GABA, DMAE, Cysteamine, and Bakuchiol for Skin Whitening and Anti-Aging (PHASE2)
- Use of Cysteamine in the Treatment of Cystinosis
- Cystinosis and Mitochondrial Metabolism (NA)
- A Cohort of Patients With Cystinosis : Compliance to Cysteamine and Neurological Complications (NA)
- PK and PD Study of NPI-001 and Cysteamine Bitartrate (PHASE1, PHASE2)
- DFT383 in Pediatric Participants With Nephropathic Cystinosis (PHASE1, PHASE2)
- A Study to Assess TTI-0102 vs Placebo in MELAS Patients (PHASE2)
- A Dose-ranging Study of TTI-0102 in Adults and Children With Leigh Syndrome Spectrum (LSS) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CYSTEAMINE HYDROCHLORIDE CI brief — competitive landscape report
- CYSTEAMINE HYDROCHLORIDE updates RSS · CI watch RSS
Frequently asked questions about CYSTEAMINE HYDROCHLORIDE
What is CYSTEAMINE HYDROCHLORIDE?
How does CYSTEAMINE HYDROCHLORIDE work?
What is CYSTEAMINE HYDROCHLORIDE used for?
What drug class is CYSTEAMINE HYDROCHLORIDE in?
When was CYSTEAMINE HYDROCHLORIDE approved?
What development phase is CYSTEAMINE HYDROCHLORIDE in?
What are the side effects of CYSTEAMINE HYDROCHLORIDE?
What does CYSTEAMINE HYDROCHLORIDE target?
Related
- Drug class: All Cystine-depleting agents drugs
- Target: All drugs targeting Cystine
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Corneal cystine crystal deposits in cystinosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing